BEUDAMED
    FDA Recall Terminated

    ExactaMix 1200 and 2400 Compounders. Used as an automated pumping system that compounds multiple sterile ingredients into a finished solution.

    Recall: Z-1752-2013 · Initiated June 4, 2013

    Recall

    Recall Number
    Z-1752-2013
    Event Number
    65215
    Firm
    Baxa Corporation
    FEI Number
    1419106
    Product Code
    LHI
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 4, 2013
    Posted
    July 18, 2013
    Terminated
    October 16, 2015
    Address
    9540 Maroon Cir, Unit 400, Englewood, CO, 80112-5731

    Description

    ExactaMix 1200 and 2400 Compounders. Used as an automated pumping system that compounds multiple sterile ingredients into a finished solution.

    Reason

    Baxter Healthcare is recalling certain ExactaMix automated compounding devices due to the complementary metal oxide semi-conductor battery failure resulting in resetting the internal clock of the device to midnight December 31, 2010.

    Action

    On 6/04/13, customers were notified by 1st class mailing with mitigating instructions including reminding customers that the battery failure results in a failure of the ExactaMix system to alert the user to replace the disposable set after 24 hours of use. Users should not rely on the alert to trigger the daily replacement of disposable sets. Users should also confirm the correct time and date at the setup of each use. If the compounder displays an incorrect time and date, customers are to contact Baxter Technical Support.

    Distribution

    Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Canada, Latin America, Europe/Middle East/Africa, and Taiwan.

    Quantity

    753 units